scPharmaceuticals Announces Data Presentations at the Heart Failure Society of America 2022 Annual Scientific Meeting

October 3, 2022 — scPharmaceuticals Inc., a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced two poster presentations, including a late breaker, at the Heart Failure Society of America (HFSA) 2022 Annual Meeting, which is being held September 30 – October 3, in Washington DC. 

“We are very pleased to have an opportunity to present scientific data at this year’s HFSA Annual Scientific Meeting, which is among the most important and well attended gatherings of heart failure experts each year,” stated John Tucker, chief executive officer of scPharmaceuticals. “The two presentations highlight the significant potential benefits – both to patients and payers – of an alternative approach to the management of congestion in patients with heart failure outside of the hospital. We believe FUROSCIX (furosemide injection), if approved, represents a potential new model for the treatment of congestion in patients with heart failure by allowing IV-equivalent diuresis at home, thus potentially reducing costly hospital admissions and readmissions.” 

“We are eagerly approaching our October 8 FUROSCIX PDUFA target action date, and, assuming FDA approval, are well prepared to initiate a robust commercial launch of FUROSCIX in 2022,” Tucker concluded. 

Details of the presentations are as follows: 

Subjects who received FUROSCIX demonstrated augmented decongestion compared with patients receiving enhanced oral diuretics as demonstrated by: 

Improved diuresis as measured by a greater reduction in body weight from baseline at study day 3 (2.8 kg vs 0.8 kg, p=0.035); 

• Improvement from baseline in mean 5-point dyspnea score at day 3 (-0.5 vs. 0.1, p=0.019); 
• Greater number of patients with markedly or moderately better shortness of breath based on 7-point dyspnea at day 3 (44% vs 6%, p=0.006); 
• Clinically relevant improvement from baseline in quality of life as measured by Kansas City Cardiomyopathy questionnaire – 12 (KCCQ-12) summary score at study days 7 and 30 of 8.9 points and 9.3 points, respectively; and 
• An increase of 55.8 meters in the average six-minute walk distance at day 30 (36.7 vs -19.1 meters, p=.012). 

The win-ratio for the hierarchical endpoint of cardiovascular death, heart failure hospitalization, urgent ED/clinic visit for heart failure and the percentage change in NT-proBNP from baseline at day seven was 1.11 (95% Confidence Interval: 0.48-2.50) favoring the FUROSCIX group. 

During the 30-day study period, subjects in the FUROSCIX group spent an average of 23.2 days heart failure event free compared to 14.3 in subjects receiving enhanced oral diuretics. 

In the FUROSCIX group, 14.7% of subjects had a serum potassium level that was less than 3.5 mEq/L during the 30-day study and was managed effectively with oral potassium supplements. 

Conclusion: Subjects receiving subcutaneous FUROSCIX demonstrated augmented decongestion as evidenced by a greater reduction in body weight, better dyspnea scores, greater exercise capacity and improvement of health-related quality of life compared with patients receiving enhanced oral diuretics, or standard treatment in a phase 2, pilot study. The favorable results in the AT HOME-HF Pilot Study support conducting an adequately powered study. 

Conclusion: An alternative outpatient heart failure management may allow many patients to avoid the need for short hospitalizations with its potential complications and healthcare costs. 

For more information: www.scPharmaceuticals.com